Benazepril HCl 40 mg Tablets, Fasting

NCT00836576 | Completed Phase 1

• 1 other identifier: 01002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this randomized, single-dose, two-way crossover evaluation is to compare the oral bioavailability of a test benazepril HCl formulation (TEVA Pharmaceutical Industries Ltd.) to an equivalent oral dose of the commercially available benazepril HCl (Lotensin®, Novartis Pharmaceuticals Corporation) in a test population of 40 adults under fasting conditions.

Conditions

Healthy

Keywords

Bioequivalence; Healthy Subjects

Outcome Measures

Primary Outcomes (3)

• Bioequivalence based on Cmax for Benazepril

  Blood samples collected over 96 hours

• Bioequivalence based on AUC0-inf for Benazepril

  Blood samples collected over 96 hour period

• Bioequivalence based on AUC0-t for Benazepril

  Blood samples collected over 96 hour period

Secondary Outcomes (3)

• Cmax results for Benazeprilat

  Blood samples collected over 96 hour period

• AUC0-inf results for Benazeprilat

  Blood samples collected over 96 hour period

• AUC0-t results for Benazeprilat

  Blood samples collected over 96 hour period

Study Arms (2)

1

EXPERIMENTAL

Drug: Benazepril HCl 40 mg Tablets

2

ACTIVE COMPARATOR

Drug: Lotensin® 40 mg Tablets

Interventions

Benazepril HCl 40 mg Tablets DRUG

1 x 40 mg, single-dose fasting

1

Lotensin® 40 mg Tablets DRUG

1 x 40 mg, single-dose fasting

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sex: Male and Female; similar proportions of each preferred.
• Age: At least 18 years.
• Subjects must have a minimum weight of at least 110 pounds.
• Qualifying subjects must be in good health and physical condition as determined by medical history, complete physical examination, and laboratory tests, all obtained within four (4) weeks prior to study start. The subject may not have a history of significant past illness expected to affect the investigation. The normal status of subjects will be confirmed by the following procedures:
• Laboratory Tests: Hemoglobin, hematocrit, RBC, WBC, differential count, serum electrolytes (Na, K, Cl), fasting blood glucose, BUN, bilirubin, creatinine, AST, ALT, LDH, alkaline phosphatase, and urinalysis. HIV, Hepatitis B, Hepatitis C, and drugs of abuse testing will be done for screening purposes only. Laboratory values which are greater than ± 20% of the normal range will not qualify unless specifically accepted (with comment) by the Principal Investigator. Results of HIC, Hepatitis B, Hepatitis C, and drugs of abuse must be negative or non-reactive for the subject to qualify for the study. Additional drugs of abuse testing will be done at check-in for each period. Tests are to be negative as a requirement for dosing. Female subjects will have a urine pregnancy test done at screening and prior to each study period at check-in.
• Electrocardiogram: A 12-lead electrocardiogram will be obtained for all subjects. The original tracings, plus interpretation, will be included in the case report form packet.
• Subjects must read and sign the Consent Form.

You may not qualify if:

• In addition one of the conditions listed below will exclude a subject from the study:
• History of treatment for alcoholism, drug abuse, or substance abuse within the past 24 months.
• History of malignancy, stroke, diabetes, cardiac, renal or liver disease, or other serious illness.
• History of treatment for asthma within the past five (5) years.
• History of treatment for any gastrointestinal disorder within the past five (5) years.
• History of neutropenia.
• History of hyperkalemia.
• History of angioedema.
• History of impaired renal function.
• History of persistent nonproductive cough.
• Females who are pregnant or lactating.
• History of hypersensitivity to benazepril HCl, or any angiotensin-converting enzyme (ACE) inhibitor.
• Conditions upon screening which might contraindicate or require that caution be used in the administration of benazepril HCl, including:
• Sitting systolic blood pressure below 90 mmHg, or diastolic pressure below 50 mmHg.
• Heart rate less than 50 beats per minute after a 5-minute rest in a seated position.

Sponsors & Collaborators

• Teva Pharmaceuticals USA: lead

Study Sites (1)

Gateway Medical Research, Inc.

Saint Charles, Missouri, 63301, United States

Location

MeSH Terms

Interventions

benazepril

Study Officials

• Thomas Siler, M.D.

  Cetero Research, San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 3, 2009
• First Posted: February 4, 2009
• Study Start: February 1, 2001
• Primary Completion: March 1, 2001
• Study Completion: March 1, 2001
• Last Updated: August 19, 2024

Record last verified: 2024-08

Locations

US (1)